MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. LAMINAR; UNIT, PHACOFRAGMENTATION

Model Number	OPOHF20L
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative information: age at time of event: unknown/not provided.Date of birth and gender: unknown/not provided.Patient weight: unknown/not provided.Ethnicity and race: unknown/not provided.Date of event: unknown/not provided.Telephone number: (b)(6).A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a piece of opaque foreign matter entered patient's eye during irrigation/aspiration procedure.The foreign matter was immediately removed with forceps by the surgeon.Procedure was successfully completed with one minute delay.The foreign matter was collected.It was alleged that the foreign mater looked like a fragment originated from phaco tip sleeve.There was no patient injury.No further information provided.
Additional Manufacturer Narrative
Device evaluation: a transparent particle was returned inside a sterile pouch, fixed in place with tape.No phaco sleeve or original packaging were returned.The particle was forwarded to an external lab for material analysis.The foreign material was identified as a silicone species similar to polydimethylsiloxane by comparison with a reference from eurofins eag's library.Without the sleeve being returned, the origin of the silicone particle cannot be determined.However, the opohf20l irrigation sleeve is violet in color.The returned particle is colorless, therefore it is unlikely that it originated from the sleeve.Manufacturing record review: a review of records related to the devices showed all devices meet material, assembly, and performance specifications at the time of product release.Based on the information obtained, there is no indication of product malfunction or product deficiency.Johnson & johnson surgical vision will continue to monitor this type of complaints per global complaint trending.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: LAMINAR
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 31 technology drive; irvine CA 92618
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 14232386
• Report Number: 3012236936-2022-01110
• Device Sequence Number: 14554413
• Product Code: HQC
• UDI-Device Identifier: 05050474535312
• UDI-Public: (01)05050474535312(17)240423(10)60291931
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K844373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/23/2024
• Device Model Number: OPOHF20L
• Device Catalogue Number: OPOHF20L
• Device Lot Number: 60291931
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SIGNATURE CONSOLE, ELLIPS FX PHACO HANDPIECE.
• Patient Sex: Unknown